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NCT02193282 · ClinicalTrials.gov registry record · Phase 3
Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)
A Phase 3 study of Stage IIIA Lung Non-Small Cell Cancer AJCC v7 and Lung Non-Squamous Non-Small Cell Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 390
- Enrollment target
- 20
- Study locations
NCT02193282: Active Phase 3 study of Stage IIIA Lung Non-Small Cell Cancer AJCC v7 and Lung Non-Squamous Non-Small Cell Carcinoma, sponsored by National Cancer Institute (NCI).
NCT02193282 is a Phase 3 study of Stage IIIA Lung Non-Small Cell Cancer AJCC v7 and Lung Non-Squamous Non-Small Cell Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 390 participants, below the 1,562-participant average among 6 other Stage IIIA Lung Non-Small Cell Cancer AJCC v7 trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02193282, a Phase 3 study of Stage IIIA Lung Non-Small Cell Cancer AJCC v7 and Lung Non-Squamous Non-Small Cell Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 390 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III ALCHEMIST trial studies how well erlotinib hydrochloride compared to observation works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery (resected). Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Estimated using the method of Kaplan-Meier survival curves and a 1-sided stratified log rank test (accounting for all the stratification factors) will be used to compare OS between the two arms. Cox proportional hazards model (including time varying coefficients as necessary) will be used to assess whether the distribution of OS times differ with respect to treatment regimen after having adjusted for the stratification factors as well as other potential prognostic and treatment covariates.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Clinical Observation
- DRUG Erlotinib Hydrochloride
- OTHER Placebo Administration
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Regional Hospital - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- Southern Cancer Center PC-Daphne - Daphne
- Southern Cancer Center PC-Mobile - Mobile
- Southern Cancer Center PC-Providence - Mobile
- Southern Cancer Center PC-Springhill - Mobile
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2015-02-11 |
| Est. Completion | 2027-02-03 |
| Phase | Phase 3 |
What the registry record for NCT02193282 still lists
NCT02193282 is an interventional study that assigns participants to a tested intervention. The registered 390 participants enrollment target is mid-sized for trials with a published cap, below the 1,562-participant average among 6 other Stage IIIA Lung Non-Small Cell Cancer AJCC v7 trials with a reported enrollment target (75% lower).
The record links to 6 conditions, with Stage IIIA Lung Non-Small Cell Cancer AJCC v7 appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02193282 names 20 study sites across 4 states, led by Alaska, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT02193282 about?
NCT02193282 is a clinical study titled "Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)". This phase III ALCHEMIST trial studies how well erlotinib hydrochloride compared to observation works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery (resected). Erlotinib hydrochloride may stop the growth of tumor cells by blocking some...
What is the current status of trial NCT02193282?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 390 participants. The study started on 2015-02-11. Estimated completion is 2027-02-03.
What conditions does trial NCT02193282 study?
This clinical trial studies the following conditions: Stage IIIA Lung Non-Small Cell Cancer AJCC v7, Lung Non-Squamous Non-Small Cell Carcinoma, Stage IB Lung Non-Small Cell Carcinoma AJCC v7, Stage II Lung Non-Small Cell Cancer AJCC v7, Stage IIA Lung Non-Small Cell Carcinoma AJCC v7.
What interventions are being tested in trial NCT02193282?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Clinical Observation (OTHER), Erlotinib Hydrochloride (DRUG), Placebo Administration (OTHER).
Who is sponsoring clinical trial NCT02193282?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02193282 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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